Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)

Allergan

Status and phase: Completed; Phase 4

Conditions: Normal Tension Glaucoma; Glaucoma, Open-Angle

Treatments: Drug: brimonidine tartrate/timolol malate Ophthalmic Solution; Drug: bimatoprost ophthalmic solution 0.01%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02863705

CMO-AP-EYE-0428

Details and patient eligibility

About

The objective of this study is to evaluate the long-term efficacy and safety of COMBIGAN® (brimonidine tartrate/timolol malate) in patients only using COMBIGAN® (brimonidine tartrate/timolol malate) and also in patients who require additional IOP lowering with LUMIGAN® (bimatoprost) 0.01%.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Primary open angle glaucoma (Regardless of Intraocular pressure)
• Previous history of topical beta-blocker use and insufficiently controlled IOP

Exclusion criteria

• Pigmentary or exfoliative glaucoma
• History of angle-closure or an occludable angle by gonioscopy
• Prior filtration or laser iridotomy
• Argon laser trabeculoplasty or Selective laser trabeculoplasty performed less than 6 months
• History or signs of chronic inflammatory eye disease, ocular trauma, or potentially progressive retinal disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

COMBIGAN®

Experimental group

Description:

One drop of COMBIGAN® in the affected eye, administered twice daily for 12 months

Treatment:

Drug: brimonidine tartrate/timolol malate Ophthalmic Solution

COMBIGAN® + LUMIGAN® 0.01%

Experimental group

Description:

LUMIGAN® will be administered once daily in the evening 5 minutes after COMBIGAN® instillation in patients who require additional IOP lowering.

Treatment:

Drug: bimatoprost ophthalmic solution 0.01%

Drug: brimonidine tartrate/timolol malate Ophthalmic Solution